MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-24 for DIMENSION? XPAND CLINICAL CHEMISTRY SYSTEM manufactured by Siemens Healthcare Diagnostics Inc- Brookfield.
[38984469]
Analysis of the instrument and instrument data indicate that cause for the discrepant high siro result was a problem with the r2 reagent transfer arm. A siemens healthcare field service engineer was dispatched to the site and replaced r2 reagent transfer arm and checked probe alignments to resolve the issue. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[38984470]
A high result on siro was questioned by the physician. The following day, the same sample was diluted 1:5 and a lower result was obtained. A new draw was performed and the siro result matched the diluted sample result it is unknown if patient treatment was altered or prescribed on the basis of the discrepant high siro result. There was no report of adverse health consequences as a result of the discrepant high siro result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00101 |
| MDR Report Key | 5458373 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-24 |
| Date of Report | 2016-02-01 |
| Date of Event | 2016-01-28 |
| Date Mfgr Received | 2016-02-01 |
| Date Added to Maude | 2016-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD SZYMANSKI |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317672 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? XPAND CLINICAL CHEMISTRY SYSTEM |
| Generic Name | DIMENSION? XPAND PLUS WITH HM INTERNATIONAL |
| Product Code | NRP |
| Date Received | 2016-02-24 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Brand Name | DIMENSION? XPAND CLINICAL CHEMISTRY SYSTEM |
| Generic Name | DIMENSION? XPAND PLUS WITH HM INTERNATIONAL |
| Product Code | JJE |
| Date Received | 2016-02-24 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-24 |